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MR Evidence of Cardiac Inflammation Post-Stroke

ConditionsStroke, IschemicInflammationMyocardial Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLuciano A. Sposato

About this trial

The present study is an investigator initiated, single-centre, prospective, proof-of-concept cohort study aiming to enroll 44 patients with acute middle cerebral artery (MCA) ischemic stroke, involving the right (n=22) and left (n=22) MCA territories and 24 control patients with acute focal neurological symptoms but no evidence of acute brain infarct on DWI-MRI.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

History of known atrial fibrillation, prior myocardial infarction, coronary artery disease, heart failure, prior cardiovascular surgery or percutaneous intervention.

Previous stroke (occurred within 3 months before the index event)

Impaired renal function defined as a creatinine clearance <97 mL/min in men or <88 mL/min in women, according to the Cockcroft formula.

hs-TnT >100 on routine acute stroke baseline bloodwork upon admission.

Trial population

The investigators will include 44 patients with right (n=22) and left (n=22) MCA ischemic stroke. The investigators aim to include at least 50% of female patients. The investigators will include 24 participants in a control group. Participants in the control group will be patients presenting with acute stroke symptoms but no evidence of acute brain infarction on DWI-MRI imaging. Participants will be divided by sex: the investigators aim to enroll 12 female and 12 male participants. The investigators will aim to enroll participants within the same age range as the stroke participants.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Gadolinium-enhanced cardiac MRI

    Diagnostic test

    Cardiac magnetic resonance imaging (MRI) with a protocol designed to measure myocardial inflammation and fibrosis.

  • B Natriuretic Peptide

    Diagnostic test

    Measurement of B Natriuretic Peptide on patients' blood samples at 10 and 60+/-15 days.

  • Systemic inflammatory markers

    Diagnostic test

    Measurement of a panel of 92 systemic inflammatory markers on patients' blood samples at 10 and 60+/-15 days.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Cases (Ischemic stroke): Left and right middle cerebral artery ischemic stroke3 interventions
Group B: Controls (TIA): Patients with acute focal neurological symptoms without brain infarct on MRI.3 interventions

Trial outcomes

Primary outcomes

1

The severity of left ventricular myocardial inflammation on cardiac MRI within 10 days post-stroke

Proportion of left ventricular myocardium showing inflammatory changes on gadolinium-enhanced cardiac MRI

Time frame
Within 10 days of stroke onset
2

The extent of left ventricular fibrosis measured on gadolinium-enhanced cardiac MRI within 10 days of stroke onset

Proportion of left ventricular myocardium showing fibrosis on gadolinium-enhanced cardiac MRI

Time frame
Within 10 days of stroke onset

Secondary outcomes

1

Changes in left ventricular inflammation measured on gadolinium-enhanced cardiac MRI at 10 and 60±15 days post-stroke

Quantification of left ventricular inflammation measured on gadolinium-enhanced cardiac MRI

Time frame
At 60±15 days compared to first 10 days
2

Change in B-Type Natriuretic Peptide (NT-proBNP) levels in the second measurement performed at 60±15 days post-stroke relative to the plasma sample drawn within 10 days.

Change in levels of NT-proBNP between 10 and 60±15 days post-stroke

Time frame
At 60±15 days compared to first 10 days
3

Change in systemic inflammatory markers between 10 and 60±15 days post-stroke

High-performance protein biomarker panel for following 92 inflammatory biomarkers in pg/mL ADA; ARTN; AXIN1; NGF; CCL13; CCL19; CCL2; CCL20; CCL23; CCL25; CCL28; CCL3; CCL4; CCL7; CCL8; CXCL10; CXCL11; CXCL5; CXCL6; CXCL9; CDCP1; CASP8; CST5; DNER; CCL11; EIF4EBP1; FGF19; FGF21; FGF23; FGF5; FLT3LG; CX3CL1; GDNF; CXCL1; HGF; IFNG; IL1A; IL10; IL10RA; IL10RB; IL12B; IL13; IL15RA; IL17A; IL17C; IL18; IL18R1; IL2; IL2RB; IL20; IL20RA; IL22RA1; IL24; IL33; IL4; IL5; IL6; IL7; CXCL8; MMP1; KITLG; LIF; LIFR; LTA; CSF1; SIRT2; CD244;NTF3;NRTN;OSM;CD274;S100A12;TGFA;STAMBP;SLAMF1;MMP10;SULT1A1;CD6;CD5;CD8A;TSLP;TGFB1;TNF;TNFSF10;TNFSF11;TNFSF12;TNFSF14;TNFRSF11B;CD40;TNFRSF9;PLAU;VEGFA

Time frame
At 60±15 days compared to first 10 days
4

Changes in left atrial inflammation measured on gadolinium-enhanced cardiac MRI at 10 and 60±15 days post-stroke

Quantification of left atrial inflammation measured on gadolinium-enhanced cardiac MRI

Time frame
At 60±15 days compared to first 10 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Luciano A. Sposato

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Sponsor institution

McMaster University

Collaborator

Western University, Canada

Collaborator

Source ClinicalTrials.gov
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